510(k) K252090

Pterygoid Indication for GM Helix Implants by JJGC Indústria e Comércio de Materiais Dentários S.A. — Product Code DZE

K252090 is an FDA 510(k) premarket notification submitted by JJGC Indústria e Comércio de Materiais Dentários S.A. for the device "Pterygoid Indication for GM Helix Implants". The FDA issued a decision of Substantially Equivalent on December 12, 2025. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. JJGC Indústria e Comércio de Materiais Dentários S.A. has at least 10 other 510(k) clearances on record.